A Clinical Study Assessing Efficacy of an Herbal Blend on Menopausal Symptoms and Quality of Life

This 12-week study is a randomized, placebo-controlled study assessing the efficacy of an herbal blend on menopausal symptoms and quality of life.

Study Overview

• Status: Unknown
• Conditions: Menopause
• Intervention / Treatment: Dietary supplement: phytoestrogen herbal blend; Other: Placebo

Detailed Description

The purpose of this study is to evaluate changes in menopause symptoms after taking an herbal supplement daily for 12 weeks compared to placebo (a tablet that does not have active ingredients). This is a remote study, meaning all study data will be collected via the ClaimIt app, with the exception of a screening lab appointment and a Week 12 lab appointment.Participants will be asked to report on study compliance and respond to a series of questionnaires relating to symptoms of menopause, hot flashes, and quality of life.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32817
      • ObvioHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Females between 40 and 65 years of age

• Report experiencing moderate to severe menopausal symptoms, characterized as including all of the following:

  • Total Score of 11 or greater on the Greene Climacteric Scale (GCS) Questionnaire
  • Self-reported frequent hot flashes experienced (estimated minimum of 28 during the past week, or an average of a minimum of 4 in a typical day)
  • Absence of a regular menstrual cycle, defined as either: an irregular cycle for at least 6 months, or the absence of menses for 3 or more months
• Agreement to maintain current level of physical activity throughout the study period
• Willingness and ability to follow the procedures of the study
• Willingness and ability to provide informed consent

Exclusion Criteria:

• Participant with a Body Mass Index (BMI) ≥ 30mg/kg2
• Participant who has had both ovaries removed
• Women who are pregnant, breastfeeding, or planning on becoming pregnant during the course of the study
• A history of breast cancer or a positive mammogram
• A history of uterine cancer or an abnormal pap smear
• Abnormal vaginal bleeding (not related to menstrual irregularity)
• Liver disease
• A history of clinically diagnosed depression that a medical professional recommended should be medically treated
• A history of clinically diagnosed hypertension (systolic of 140 mmHg or greater or diastolic of 90 mmHg or greater)
• Hyperthyroidism determined by thyroid stimulating hormone (TSH) screening
• Any unstable medical condition as determined by the Principal Investigator (PI)
• Any significant clinical or laboratory abnormality identified by the PI
• Any change in the use of dietary supplements in the 2-month prior to enrollment
• The use of any product indicated for menopause symptoms in the 2 months prior to enrollment including: prescription drugs (e.g. estrogen/progestins), over-the-counter supplements (e.g. black cohosh, soy isoflavones, evening primrose oil, phytoestrogens, etc), or a significant change in diet to include more soy foods.
• The use of any psychiatric drugs in the 6 months prior to enrolling
• Self-reported abuse of drugs or alcohol
• Any smoking of cigarettes, vaping or e-cigarettes, or consumption of other tobacco products within the past 6 months
• Planned donation of blood during or up to 30 days after completion of the study
• An allergy to any ingredient in the herbal blend product or placebo
• A sensitivity to botanical extracts
• Previous participation in a clinical research study less than 30 days prior to randomization to a treatment group
• Any other condition that in the investigator's opinion may adversely affect the participant's ability to complete the study, or may pose a significant risk to the participant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Investigational Herbal Blend; A phytoestrogen herbal blend	Dietary supplement: phytoestrogen herbal blend; phytoestrogen herbal blend
PLACEBO_COMPARATOR: Placebo; Tablet without active ingredients	Other: Placebo; Tablet without active ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Menopausal Symptoms	Change from baseline in global menopausal symptoms assessed by the Greene Climacteric Questionnaire at Week 12. The Greene Climacteric Questionnaire is a 21-item validated questionnaire that provides a measurement of global menopause symptoms, grouping questions into psychological, physical, vasomotor, and sexual domains. Participants answer on a 4-point scale. Each response is given a numerical value from 0 to 3 points respectively, and the sum total of their 21-point responses is calculated as their GCS score.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Menopausal Symptoms	Change from baseline in global menopausal symptoms assessed by Greene Climacteric questionnaire at weeks 2, 4 and 8. The Greene Climacteric Questionnaire is a 21-item validated questionnaire that provides a measurement of global menopause symptoms, grouping questions into psychological, physical, vasomotor, and sexual domains. Participants answer on a 4-point scale. Each response is given a numerical value from 0 to 3 points respectively, and the sum total of their 21-point responses is calculated as their GCS score.	8 weeks
Incidence/severity of hot flash episodes	Change from baseline in frequency of hot flash episodes as measured by self-report of incidence of hot flashes at week 2, 4, 8, and 12, considering: Total number of episodes; Number of episodes per category of intensity: mild, moderate, severe and very severe	12 weeks
Feelings of fatigue	Change from baseline in feelings of fatigue as measured by Chalder Fatigue Scale questionnaire scores at weeks 4, 8, and 12. The CFS is an 11-point questionnaire that provides a numerical value for overall symptoms of fatigue. Participants are asked to answer about their experience of fatigue related symptoms on a 4-point scale including "Less than usual", "No more than usual", "More than usual" and "Much more than usual" on the first 10 questions. On the final question the options are "Better than usual", "No worse than usual", "Worse than usual" and "Much worse than usual". Each score is given a numerical score of 0-3 respectively, and a total calculated as the sum of the 11 responses.	12 weeks
Health-related quality of life (EQ-VAS)	Change from baseline in health-related quality of life as measured by the EuroQol visual analogue scale (EQ-VAS) at weeks 2, 4, 8, and 12. The EQ-VAS is a questionnaire that requires participants to report self-perception of how good their health is that day on a 100-point visual analogue scale.	12 weeks
Vaginal dryness	Change from baseline in self-reported vaginal dryness on a five-point scale as measured by response to a study-specific questionnaire item at weeks 2, 4, 8, and 12	12 weeks
Perception of wellness	Participant perception of wellness after 12 weeks of supplementation, as documented by listed responses to open-ended questions in a study-specific questionnaire.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood biomarkers	Chemistry Panel including liver enzymes and CBC	12 weeks
Incidence of AEs	Incidence of Adverse Events (AEs) observed during the treatment period, classified by the investigator as to intensity, relationship to study product/protocol, and seriousness	12 weeks

Collaborators and Investigators

• Sponsor: i-Health, Inc.
• Collaborators: ObvioHealth

Publications and helpful links

General Publications

• Utian WH, Archer DF, Bachmann GA, Gallagher C, Grodstein Fn, Heiman JR, Henderson VW, Hodis HN, Karas RH, Lobo RA, Manson JE, Reid RL, Schmidt PJ, Stuenkel CA; North American Menopause Society. Estrogen and progestogen use in postmenopausal women: July 2008 position statement of The North American Menopause Society. Menopause. 2008 Jul-Aug;15(4 Pt 1):584-602. doi: 10.1097/gme.0b013e31817b076a.
• Chlebowski RT, Kuller LH, Prentice RL, Stefanick ML, Manson JE, Gass M, Aragaki AK, Ockene JK, Lane DS, Sarto GE, Rajkovic A, Schenken R, Hendrix SL, Ravdin PM, Rohan TE, Yasmeen S, Anderson G; WHI Investigators. Breast cancer after use of estrogen plus progestin in postmenopausal women. N Engl J Med. 2009 Feb 5;360(6):573-87. doi: 10.1056/NEJMoa0807684.
• Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. doi: 10.1001/jama.288.3.321.
• Lethaby A, Marjoribanks J, Kronenberg F, Roberts H, Eden J, Brown J. Phytoestrogens for menopausal vasomotor symptoms. Cochrane Database Syst Rev. 2013 Dec 10;(12):CD001395. doi: 10.1002/14651858.CD001395.pub4.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 28, 2019
• Primary Completion (ANTICIPATED): April 4, 2020
• Study Completion (ANTICIPATED): April 4, 2020

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (ACTUAL): January 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Nutritional Supplement
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens, Non-Steroidal; Estrogens; Phytoestrogens
• Other Study ID Numbers: OBVIO-DSM-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No